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This study compares two treatment approaches for pilonidal sinus disease: laser treatment alone versus laser treatment combined with phenol application. Pilonidal sinus is a common condition that affects young adults and can cause significant discomfort and time off work.
Participants will be randomly assigned to receive either laser treatment only (Group A) or laser treatment plus phenol application (Group B). Both treatments are minimally invasive and performed under local anesthesia as day surgery procedures.
The main goal is to determine if adding phenol to laser treatment speeds up the healing process (epithelialization) and improves patient outcomes. We will measure healing time, pain levels, return to daily activities, and quality of life over a 3-month follow-up period.
This research may help develop more effective treatment protocols that reduce healing time and improve patient comfort for people with pilonidal sinus disease.
This prospective randomized controlled clinical trial investigates whether adding crystallized phenol to laser treatment improves epithelialization and healing outcomes in patients with pilonidal sinus disease. The study will be conducted at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital.
Study Design: 130 patients meeting inclusion criteria will be randomly assigned using computer randomization to two treatment groups (65 patients each):
Group A: Laser treatment only using SiLaC (Sinus Laser Closure) technique Group B: Combined phenol application followed by laser treatment
Treatment Procedures:
Group A receives local anesthesia, pilonidal sinus area cleaning, assessment of sinus openings, and laser probe application into sinus channels.
Group B receives local anesthesia, sinus area cleaning and curettage, crystallized phenol application into sinus channels, neutralization with saline after a specified time, followed by laser treatment.
Both groups receive standard post-operative wound care instructions and same-day discharge.
Follow-up Schedule:
Preoperative assessment Postoperative visits at 2 weeks, 4 weeks, and 3 months Clinical examination for epithelialization status Pain assessment using Visual Analog Scale (VAS 0-10) Quality of life evaluation using SF-36 questionnaire
Statistical Analysis: R software will be used for statistical analysis. Student's t-test or Mann-Whitney U test for continuous variables, chi-square test for categorical variables, and paired t-test for pre/post-treatment comparisons. Statistical significance set at p<0.05.
Primary Outcome: Time to complete epithelialization Secondary Outcomes: Postoperative pain scores, return to daily activities time, patient satisfaction, quality of life scores, and complication rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Treatment Only | Active Comparator | Participants receive laser treatment (SiLaC - Sinus Laser Closure) under local anesthesia. The pilonidal sinus area is cleaned, sinus openings are evaluated, and laser probe is inserted into sinus channels for ablation. Standard post-operative wound care is provided with same-day discharge. |
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| Crystallized Phenol | Experimental | Participants receive combined treatment under local anesthesia. First, the pilonidal sinus area is cleaned and curetted, then crystallized phenol is applied into sinus channels. After a specified time, phenol is neutralized with normal saline, followed by laser treatment (SiLaC) application. Standard post-operative wound care is provided with same-day discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Treatment | Procedure | Minimally invasive laser ablation procedure performed under local anesthesia for pilonidal sinus treatment. Laser energy is delivered through a fiber optic probe inserted into the sinus tract to achieve thermal ablation of the sinus cavity. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Epithelialization | Time required for complete epithelialization of the pilonidal sinus wound, assessed by clinical examination during follow-up visits. Complete epithelialization is defined as full closure of the wound with healthy epithelial tissue covering the entire treated area. | From date of surgery until complete epithelialization is achieved, assessed up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Scores | Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable) | Measured at 2 weeks, 4 weeks, and 3 months post-surgery |
| Return to Daily Activities Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital | Recruiting | Istanbul | Other | 34785 | Turkey (Türkiye) |
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Two parallel groups: Group A receives laser treatment only, Group B receives combined phenol and laser treatment
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Open-label study due to the nature of surgical interventions which cannot be blinded to participants or care providers
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| Crystallized Phenol | Drug | rystallized phenol is applied directly into the pilonidal sinus channels after cleaning and curettage. The phenol remains in contact for a specified duration before being neutralized with normal saline irrigation. |
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Time required for patients to return to normal daily activities and work, measured in days from surgery
| From date of surgery until return to normal activities, assessed up to 3 months |
| Complication Rate | Incidence of post-operative complications including infection, wound dehiscence, bleeding, or other adverse events | From surgery through 3 months follow-up |
| Patient Satisfaction- VAS score Patient Satisfaction Patient Satisfaction | Patient satisfaction measured using Visual Analog Scale (VAS) ranging from 0 (completely dissatisfied) to 10 (completely satisfied), where higher scores indicate better satisfaction | At 3 months post-surgery |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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